摘要
目的:分析生物制品临床试验现状,规范临床试验管理,为临床试验发展提供依据。方法:选择2022年期间开展的临床试验项目,从专业科室、适应症及不良事件3个方面统计分析徐州医科大学附属医院生物制品临床试验现状。结果:2022年期间共开展临床试验135项,化学药品、生物制品和中药分别占比56.30%、41.48%和2.22%。生物制品的Ⅰ~Ⅳ期临床试验分别占比16.07%、21.43%、60.71%和1.79%。其中,肿瘤科和血液科分别占比19.64%与17.86%,血液系统疾病生物制品临床试验全国占比最高(30.95%),其主要不良事件为肝功能受损与血细胞下降,分别为11.86%与34.02%。结论:各方应积极发展以血液系统疾病为代表的生物制品临床试验,建立并完善临床试验管理体系,保障临床试验的顺利开展。
Objective:To analyze the current situation of clinical trials of biological products,standardize clinical trial management,and provide basis for the development of clinical trials.Methods:The clinical trials carried out during 2022 are selected to analyze the clinical trials of biological products in Affiliated Hospital of Xuzhou Medical University from three aspects:professional departments,indications and adverse events.Results:A total of 135 clinical trials are carried out during 2022,with chemical drugs,biological products and traditional Chinese medicines accounting for 56.30%,41.48%and 2.22%respectively.Phase I to IV clinical trials of biological products account for 16.07%,21.43%,60.71%and 1.79%,respectively.Among them,the departments of oncology and hematology account for 19.64%and 17.86%respectively,but the clinical trials of biological products of blood system diseases accounted for the highest proportion in China(30.95%),and the main adverse events are liver function impairment and blood cell decline,which are 11.86%and 34.02%,respectively.Conclusion:All departments should encourage the development of clinical trials of biological products represented by blood system diseases,establish and improve clinical trial management system,and ensure the smooth development of clinical trials.
作者
蒋海静
朱红
葛佳佳
仇思维
郭妮娜
黄贝贝
JIANG Haijing;ZHU Hong;GE Jiajia;QIU Siwei;GUO Nina;HUANG Beibei(The Affiliated Hospital of Xuzhou Medical University,Xuzhou 221300,China)
出处
《生物化工》
CAS
2024年第5期80-82,87,共4页
Biological Chemical Engineering
关键词
生物制品
临床试验
不良事件
biological products
clinical trails
adverse events
作者简介
蒋海静(1989-),女,江苏淮安人,硕士,主管药师,研究方向为药理学;通信作者:黄贝贝(1990-),女,江苏徐州人,硕士,主管药师,研究方向为药理学。E-mail:bei_huang1993@163.com。
